Summary

The purpose of this study is to: (a) adapt existing vaginal USPE items/instruments for
evaluation of similar elements of rectal compartment use; (b) develop these scales using 3
distinct semi-solid formulations that represent a range of physicochemical and rheological
properties of microbicides that are currently being designed for dual compartment use; and
(c) develop novel USPE instruments to capture the experience of product use in the context
of receptive anal intercourse (RAI) in both male and female cohorts.

Primary Outcomes

time frame:
at completion of user evaluation of all 3 products (approximately 6-12 weeks post-enrollment)

Secondary Outcomes

Measure

User Perception Scale Scores

time frame:
3 web-based surveys over an average of 6-12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
- All participants must meet all of the inclusion criteria to participate in this
study.
- Eligible male participants must be 18 years of age or older
- Eligible female participants must be 18-45 years of age
Inclusion criteria include men and women who:
- Report receptive anal intercourse (RAI) at least twice in the past 6 months,
- Are willing to use each study product in conjunction with RAI on at least one
occasion in each data collection period (resulting in a minimum of 3 RAI events
during each product evaluation period; on average every 2 weeks, all 3 products
across an average of 6 -12 weeks))
- Are willing and able to respond to study data collection systems via phone and
internet, attend all study visits, and participate in in-depth qualitative and
cognitive interviews
Exclusion Criteria:
- Male and female participants will be ineligible if they:
- Have a sensitivity or allergy to vaginal, anal, or rectal products,
- Have a sensitivity or allergy to any of the ingredients contained in the study
products,
- Are HIV positive at baseline, or have a known HIV-positive sexual partner,
- Have an active rectal or reproductive tract infection requiring treatment per
current Centers for Disease Control (CDC) guidelines or symptomatic urinary
tract infection (UTI). Infections requiring treatment include Chlamydia (CT)*,
gonorrhea (GC)*, syphilis, active herpes simplex virus (HSV) lesions (note: HSV
seropositivity with no active genital lesions is not an exclusion criterion,
since treatment is not required), chancroid, genital sores or ulcers, and, if
clinically indicated, genital warts,
- Have current inflammatory bowel disease (IBD) or history of active IBD within
last 3 months,
- Have any other significant colorectal symptom(s) as determined by medical
history, participant self-report , or physical exam (including but not limited
to presence of any unresolved injury, infectious or inflammatory condition of
the local mucosa, presence of symptomatic external hemorrhoids, and presence of
any painful anorectal conditions that would be tender to manipulation),
- Have a nontreatable sexually transmitted disease that could, in the opinion of
the investigator/study clinician, make the patient unsuitable for the study or
unable to comply with study requirements
- Have any other clinical condition or prior therapy that, in the opinion of the
investigator/study clinician, would make the patient unsuitable for the study or
unable to comply with the study requirements,
- Are unwilling to refrain from use of nonoxynol-9 (N9) for the duration of the
study,
- Are unable or unwilling to communicate in English, or
- Are unable or unwilling to give written informed consent.
Additionally, female participants will be ineligible if they:
• Are pregnant or breastfeeding.

HIV prevention is a global public health priority. Providing efficacious prevention methods
that have the greatest likelihood of use will have a profound impact on the public's health.
Critical to their use is "acceptability." However, current conceptualizations of adherence
and acceptability fail to fully articulate and account for patterns of use and non-use.
Formulation properties are critically important to both drug delivery and the user
experience. Microbicide developers thus have the opportunity to directly control a
formulation's impact on acceptability and adherence to product use, as well as biological
product performance. Microbicide products can and should be developed such that they achieve
performance standards for both these behavioral (user experience) and biological (efficacy)
functions. By incorporating the user experience early on in the product development process,
developers will have the greatest chance of providing at-risk individuals with the best
prevention methods science can provide. Developing prevention products that can be used in
the vagina and/or the rectum and that optimize the user experience in both compartments
increases the likelihood that these products will be used consistently and correctly. The
impact on global public health has the potential to be far-reaching, decreasing HIV and
sexually transmitted infections (STI) incidence and prevalence in both women and men.
Methodology and Data Collection: This is a formative mixed methods design in which
volunteers (N~20-30; ~8-20 males; ~8-20 Females) will first be prescreened for basic study
eligibility using a brief questionnaire. Those who are interested in the study and are
eligible based on their responses to the prescreen will then complete a STI/HIV screening
and pregnancy test (for females).
During the course of the study, participants will evaluate 3 study products (i.e., distinct
semi-solid formulations that represent a range of physicochemical and rheological
properties). Each participant will be randomly assigned to the order in which they will
evaluate the 3 products. Participants will be required to complete a brief phone survey (<5
minutes) every day, beginning the day after they start their first product evaluation period
and continuing until they complete their final study visit (approximately 12-24 weeks). The
phone survey includes a short set of questions about sexual behavior and product use during
the time since the last phone survey (about 24 hours). After a sexual encounter that
includes RAI and study product use, participants will be required to complete a web survey
about their experience with the study product. After a participant has evaluated all three
products, participants complete an individual in-depth interview and a cognitive interview
with study staff about their experiences with the study product and the USPE scale items
being developed.

Trial information was received from ClinicalTrials.gov and was last updated in October 2015.